StrokeNCT06392945
Effects of Rhythmic Auditory Cueing Augments Cognitive Treadmill Walking Training in Individuals With Chronic Stroke
A study testing Cognitive Treadmill Walking Training with Rhythmic Auditory Cueing (CTW+RAC) group, Cognitive Treadmill Walking Training (CTW) group and Treadmill Walking Training (TW) in people with Stroke, run by Chang Gung University at 1 site in Taiwan.
Trial summary
The first objective of this study is to examine the superiority of the combined rhythmic auditory cueing with cognitive treadmill training (combined group) in people with stroke as compared with the cognitive treadmill walking training (cognitive group) or treadmill walking training alone (treadmill group) (Aim 1). Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Stroke
- What is being tested?
- Cognitive Treadmill Walking Training with Rhythmic Auditory Cueing (CTW+RAC) group, Cognitive Treadmill Walking Training (CTW) group and Treadmill Walking Training (TW)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTaiwan
- Study dates
- 24 May 2024to 31 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosed with first-time stroke;
- more than 6 months after stroke onset;
- able to walk 10 meters;
- no severe vision, hearing, or speech impairments;
- understand and follow the instructions and sign the Informed Consent Form;
- older than 20 years old.
Who cannot join
- orthopedic problems affecting walking or other diseases that may interfere with study participation;
- a score of less than 24 on the mini-mental state examination (MMSE);
- severe balance disorder with a total score of less than 45 points Berg Balance Scale.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Mackay Memory Hospital
Taipei
Li-Ling Chuang, Ph.D., 886-3-2118800 ext. 3177, lchuang@gap.cgu.edu.tw
Li-Ling Chuang, Ph.D.
About this study
Official title: Effects of Rhythmic Auditory Cueing Augments Cognitive Treadmill Walking Training on Community Walking Capacity, Walking Automaticity, and Social Participation in Individuals With Chronic Stroke: a Randomized Controlled Trial
The first objective of this study is to examine the superiority of the combined rhythmic auditory cueing with cognitive treadmill training (combined group) in people with stroke as compared with the cognitive treadmill walking training (cognitive group) or treadmill walking training alone (treadmill group) (Aim 1). The study's second aim is to investigate the factors affecting the improvement in community walking capacity after interventions and to explore whether changes in community walking capacity are associated with changes in participation after interventions (Aim 2).
Read the detailed description
A single-blind, randomized controlled trial is conducted at medical centers. Ninety stroke patients will be randomized to one of the three groups. All groups will receive interventions 30 minutes per time, 3 times a week, for 4 weeks. The combined group will undertake progressive treadmill walking speed while performing a cognitive task with rhythmic auditory cueing (i.e., 110% of baseline cadence). The cognitive group will receive cognitive training while walking at a progressive speed on the treadmill. The treadmill-alone group will train only in treadmill walking with progressive speed adjusted weekly. A blinded assessor will administer three assessments. All participants will be examined for gait and cognitive performance under single-task (walking only, Stroop task only) and dual-task conditions (walking while performing the Stroop task) at baseline, post-intervention, and one-month follow-up. The primary outcome measures are gait and cognition under single- and dual-task conditions. The secondary outcome measures are the 6-minute Walk Test, Mini-BESTest, Stroke Impact Scale, and Walking Ability Questionnaire.
- Conditions
- Stroke
- Being tested
- Cognitive Treadmill Walking Training with Rhythmic Auditory Cueing (CTW+RAC) group, Cognitive Treadmill Walking Training (CTW) group, Treadmill Walking Training (TW)
- Keywords
- stroke, gait rehabilitation, rhythmic auditory cueing, cognitive training, treadmill
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Treadmill Walking Training with Rhythmic Auditory Cueing (CTW+RAC) groupDevice
Participants in the CTW+RAC group participate in 12-session programs administered for 30 minutes each session, 3 times per week for 4 weeks. To increase adaptability to rhythmic auditory cueing prior to cognitive treadmill walking training, participants are required to keep stepping on their feet while listening to the auditory cueing using a metronome program (Metronome APP) for 5 minutes of warm up. Then they start walking on a treadmill with a target speed and perform a cognitive task concurrently while listening rhythmic auditory cueing. According to previous research, the target treadmill speed at week 1, week 2, week 3, and week 4 is gradually increased from 90%, 100%, 110%, to 120% baseline walking speed of comfortable walking on the ground. The beat of rhythmic auditory cueing using the Metronome APP on the smartphone is set at 110% of baseline cadence of comfortable walking on the ground based on a previous study in individuals with stroke.
Cognitive Treadmill Walking Training (CTW) groupDevice
Participants in the CTW group will participate in 12-session programs administered for 30 minutes each session, 3 times per week for 4 weeks. They will start stepping on the ground at comfortable pace for 5 minutes of warm up. Then they will start walking on a treadmill with a target speed and perform a cognitive task concurrently without rhythmic auditory cueing. Same cognitive training and target treadmill speed will be used as the CTW+RAC group during cognitive dual-task treadmill walking. Three cognitive training programs will be the verbal fluency, arithmetic, and visual distinguish tasks. The target treadmill speed will be gradually increased from 90% at week 1, to 100% at week 2, to 110% at week 3, to 120% baseline walking speed of comfortable walking on the 10 meters walk test at week 4.
Treadmill Walking Training (TW)Device
Participants in the TW group will participate in 12-session programs administered for 30 minutes each session, 3 times per week for 4 weeks. They will start stepping on the ground at comfortable pace for 5 minutes of warm up. Then they will start walking on a treadmill with a target speed only, without concurrent performing a cognitive task and no listening rhythmic auditory cueing. Same target treadmill speed will be used as the other two groups during treadmill walking. The target treadmill speed will be gradually increased from 90% at week 1, to 100% at week 2, to 110% at week 3, to 120% baseline walking speed of comfortable walking on the ground.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Treadmill Walking Training with Rhythmic Auditory Cueing (CTW+RAC) group | Experimental | The CTW+RAC group will undertake progressive treadmill walking speed while performing a cognitive task with rhythmic auditory cueing (i.e., 110% of baseline cadence). Receives: Device: Cognitive Treadmill Walking Training with Rhythmic Auditory Cueing (CTW+RAC) group |
| Cognitive Treadmill Walking Training (CTW) | Active comparator | The CTW group will receive cognitive training while walking at a progressive speed on the treadmill. Receives: Device: Cognitive Treadmill Walking Training (CTW) group |
| Treadmill Walking Training (TW) | Active comparator | The TW group will train only in treadmill walking with progressive speed adjusted weekly. Receives: Device: Treadmill Walking Training (TW) |
What is being measured
The primary outcome is the main question the study is designed to answer.
walking speed (m/s) under single-task walking and dual-task walking with the Stroop task
Participants will walk 10 meters at their preferred speed with and without the Stroop task twice, respectively. The spatiotemporal gait parameters will be examined using Physilog® sensors (Gait Up, Switzerland) and analyzed by the Gait Analysis Package software on the USB key. Walking speed (m/s) is the mean speed of forward walking, calculated in meters per second.
Measured: baseline, after 4-week intervention, one-month follow-up
swing phase asymmetry under single-task walking and dual-task walking with the Stroop task
Swing phase asymmetry (%) is the ratio of swing which compares the time in the air for the two feet, in percent.
Measured: baseline, after 4-week intervention, one-month follow-up
stride length asymmetry under single-task walking and dual-task walking with the Stroop task
Stride length asymmetry (%) is the ratio of stride length which compares the stride length for the two feet, in percent. A perfect symmetry outputs a value of 0%.
Measured: baseline, after 4-week intervention, one-month follow-up
cognitive composite score
The Stroop task is the commonly utilized dual-task paradigm and measures executive function and response inhibition, which plays a vital role during walking. Therefore, the Stroop task will be selected to assess cognitive dual-task walking. The Stroop task will be performed while sitting and walking to assess executive function under single-task and dual-task conditions. The following is the formula for calculating the cognitive composite score: Cognitive composite score of the Stroop task = [Accuracy(%)/Reaction time(milliseconds)] * 100. The better the cognitive performance of the Stroop task, the higher the cognitive composite score.
The instructions for the dual-task walking (walking + Stroop) are designed to encourage neutral prioritization between the two tasks ("walk at the preferred speed while performing the Stroop task as accurately and quickly as you can").
Measured: baseline, after 4-week intervention, one-month follow-up
Secondary outcomes (6)
Task-specific dual-task interference
Task-specific dual-task interference is calculating the motor (i.e., walking speed) or cognitive dual-task effect (DTE), which relates dual-task performance to single-task performance. For assessing dual-task interference, quantifies the combined interference of the motor and the cognitive tasks may be a more comprehensive measure of dual-task effect to provide a more accurate picture of gait automaticity
Measured: baseline, after 4-week intervention, one-month follow-up
Automaticity
Automaticity is based on the combined interference of both motor (i.e., walking speed) and cognitive DTE. The combined dual-task effect (cDTE) is a measure that quantifies automaticity while performing a dual-task.
Measured: baseline, after 4-week intervention, one-month follow-up
6-minute Walking test, 6MWT
The 6MWT is used to measure participants' walking capacity and walking endurance.The participants are asked to walk for six minutes at their own pace, resting or slowing down as needed, and the total distance (meters) of walking in six minutes.
Measured: baseline, after 4-week intervention, one-month follow-up
Stroke impact scale, SIS
The SIS was developed to measure the quality of life after a stroke. The SIS 3.0 has eight domains: strength, hand function, mobility, activities of daily living/instrumental activities of daily living (i.e., ADLs and IADLs), memory and thinking, communication, emotion, and social participation. Scores for each domain range from 0 to 100, and higher scores indicate a better health-related quality of life. Lower scores indicate more incredible difficulty in task completion during the past week or past two weeks, or past four weeks. Eight items on the social participation domain and eight items on the mobility domain of the SIS will be used to measure the social participation of individuals with chronic stroke in this study.
Measured: baseline, after 4-week intervention, one-month follow-up
Mini-Balance Evaluation System Test, Mini-BESTest
The Mini-BESTest is a reliable and valid tool for evaluating balance in people with chronic stroke. It consists of 14 items and includes four subscales: anticipatory postural adjustments, reactive postural control, sensory orientation, and dynamic gait. Each test item is rated on a three-point ordinal scale (0-2, 0=severe, 1=moderate, and 2=normal), with the total score ranging between 0 and 28 points.
Measured: baseline, after 4-week intervention, one-month follow-up
Walking ability questionnaire
Walking ability questionnaire was designed to provide a more detailed assessment of the individual's social limitations due to reduced walking ability. The questionnaire will be administered by a research assistant to rate the participant's current customary mobility of 19 ambulatory activities performed in the home (8 items) and community (11 items). Each item of walking ability is rated on a five-point ordinal scale (0-4, 0=unable to walk, 1=depend on wheel chair, 2=need assistance, 3=walking under supervision, and 4=independent walking), with the total score ranging between 0 and 76 points.
Measured: baseline, after 4-week intervention, one-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2024
- Study start24 May 2024
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung University
- Sponsor type
- University, hospital or other
- Collaborators
- National Science and Technology Council
- Responsible party
- Principal investigator, Li-Ling Chuang, Chang Gung University
- Investigators
- Li-Ling Chuang, Ph.D., Principal investigator, Chang Gung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06392945
- Sponsor's protocol ID
- NSTC 112-2314B-182-021
- Status last verified
- Mar 2026
- First submitted
- 26 Apr 2024
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Rhythmic Auditory Cueing Augments Cognitive Treadmill Walking Training on Community Walking Capacity, Walking Automaticity, and Social Participation in Individuals With Chronic Stroke: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06392945
- Acronym / sponsor ID
- NSTC 112-2314B-182-021
- Conditions
- Stroke
- Keywords
- stroke, gait rehabilitation, rhythmic auditory cueing, cognitive training, treadmill
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Chang Gung UniversityUniversity, hospital or other
- Collaborators
- National Science and Technology Council
- Study start
- 24 May 2024 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 1 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The first objective of this study is to examine the superiority of the combined rhythmic auditory cueing with cognitive treadmill training (combined group) in people with stroke as compared with the cognitive treadmill walking training (cognitive group) or treadmill walking training alone (treadmill group) (Aim 1). The study's second aim is to investigate the factors affecting the improvement in community walking capacity after interventions and to explore whether changes in community walking capacity are associated with changes in participation after interventions (Aim 2).
Detailed description
A single-blind, randomized controlled trial is conducted at medical centers. Ninety stroke patients will be randomized to one of the three groups. All groups will receive interventions 30 minutes per time, 3 times a week, for 4 weeks. The combined group will undertake progressive treadmill walking speed while performing a cognitive task with rhythmic auditory cueing (i.e., 110% of baseline cadence). The cognitive group will receive cognitive training while walking at a progressive speed on the treadmill. The treadmill-alone group will train only in treadmill walking with progressive speed adjusted weekly. A blinded assessor will administer three assessments. All participants will be examined for gait and cognitive performance under single-task (walking only, Stroop task only) and dual-task conditions (walking while performing the Stroop task) at baseline, post-intervention, and one-month follow-up. The primary outcome measures are gait and cognition under single- and dual-task conditions. The secondary outcome measures are the 6-minute Walk Test, Mini-BESTest, Stroke Impact Scale, and Walking Ability Questionnaire.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cognitive Treadmill Walking Training with Rhythmic Auditory Cueing (CTW+RAC) group | Experimental | Device: Cognitive Treadmill Walking Training with Rhythmic Auditory Cueing (CTW+RAC) groupThe CTW+RAC group will undertake progressive treadmill walking speed while performing a cognitive task with rhythmic auditory cueing (i.e., 110% of baseline cadence). |
| Cognitive Treadmill Walking Training (CTW) | Active comparator | Device: Cognitive Treadmill Walking Training (CTW) groupThe CTW group will receive cognitive training while walking at a progressive speed on the treadmill. |
| Treadmill Walking Training (TW) | Active comparator | Device: Treadmill Walking Training (TW)The TW group will train only in treadmill walking with progressive speed adjusted weekly. |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- diagnosed with first-time stroke;
- more than 6 months after stroke onset;
- able to walk 10 meters;
- no severe vision, hearing, or speech impairments;
- understand and follow the instructions and sign the Informed Consent Form;
Key exclusion criteria (3 listed)
- orthopedic problems affecting walking or other diseases that may interfere with study participation;
- a score of less than 24 on the mini-mental state examination (MMSE);
- severe balance disorder with a total score of less than 45 points Berg Balance Scale.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Treadmill Walking Training with Rhythmic Auditory Cueing (CTW+RAC) groupParticipants in the CTW+RAC group participate in 12-session programs administered for 30 minutes each session, 3 times per week for 4 weeks. To increase adaptability to rhythmic auditory cueing prior to cognitive treadmill walking training, participants are required to keep stepping on their feet while listening to the auditory cueing using a metronome program (Metronome APP) for 5 minutes of warm up. Then they start walking on a treadmill with a target speed and perform a cognitive task concurrently while listening rhythmic auditory cueing. According to previous research, the target treadmill speed at week 1, week 2, week 3, and week 4 is gradually increased from 90%, 100%, 110%, to 120% baseline walking speed of comfortable walking on the ground. The beat of rhythmic auditory cueing using the Metronome APP on the smartphone is set at 110% of baseline cadence of comfortable walking on the ground based on a previous study in individuals with stroke. | Device | Cognitive Treadmill Walking Training with Rhythmic Auditory Cueing (CTW+RAC) group |
| Cognitive Treadmill Walking Training (CTW) groupParticipants in the CTW group will participate in 12-session programs administered for 30 minutes each session, 3 times per week for 4 weeks. They will start stepping on the ground at comfortable pace for 5 minutes of warm up. Then they will start walking on a treadmill with a target speed and perform a cognitive task concurrently without rhythmic auditory cueing. Same cognitive training and target treadmill speed will be used as the CTW+RAC group during cognitive dual-task treadmill walking. Three cognitive training programs will be the verbal fluency, arithmetic, and visual distinguish tasks. The target treadmill speed will be gradually increased from 90% at week 1, to 100% at week 2, to 110% at week 3, to 120% baseline walking speed of comfortable walking on the 10 meters walk test at week 4. | Device | Cognitive Treadmill Walking Training (CTW) |
| Treadmill Walking Training (TW)Participants in the TW group will participate in 12-session programs administered for 30 minutes each session, 3 times per week for 4 weeks. They will start stepping on the ground at comfortable pace for 5 minutes of warm up. Then they will start walking on a treadmill with a target speed only, without concurrent performing a cognitive task and no listening rhythmic auditory cueing. Same target treadmill speed will be used as the other two groups during treadmill walking. The target treadmill speed will be gradually increased from 90% at week 1, to 100% at week 2, to 110% at week 3, to 120% baseline walking speed of comfortable walking on the ground. | Device | Treadmill Walking Training (TW) |
Primary outcome
walking speed (m/s) under single-task walking and dual-task walking with the Stroop task
Time frame: baseline, after 4-week intervention, one-month follow-up
Participants will walk 10 meters at their preferred speed with and without the Stroop task twice, respectively. The spatiotemporal gait parameters will be examined using Physilog® sensors (Gait Up, Switzerland) and analyzed by the Gait Analysis Package software on the USB key. Walking speed (m/s) is the mean speed of forward walking, calculated in meters per second.
swing phase asymmetry under single-task walking and dual-task walking with the Stroop task
Time frame: baseline, after 4-week intervention, one-month follow-up
Swing phase asymmetry (%) is the ratio of swing which compares the time in the air for the two feet, in percent.
stride length asymmetry under single-task walking and dual-task walking with the Stroop task
Time frame: baseline, after 4-week intervention, one-month follow-up
Stride length asymmetry (%) is the ratio of stride length which compares the stride length for the two feet, in percent. A perfect symmetry outputs a value of 0%.
cognitive composite score
Time frame: baseline, after 4-week intervention, one-month follow-up
The Stroop task is the commonly utilized dual-task paradigm and measures executive function and response inhibition, which plays a vital role during walking. Therefore, the Stroop task will be selected to assess cognitive dual-task walking. The Stroop task will be performed while sitting and walking to assess executive function under single-task and dual-task conditions. The following is the formula for calculating the cognitive composite score: Cognitive composite score of the Stroop task = [Accuracy(%)/Reaction time(milliseconds)] * 100. The better the cognitive performance of the Stroop task, the higher the cognitive composite score. The instructions for the dual-task walking (walking + Stroop) are designed to encourage neutral prioritization between the two tasks ("walk at the preferred speed while performing the Stroop task as accurately and quickly as you can").
6 secondary outcomes
Task-specific dual-task interference
Time frame: baseline, after 4-week intervention, one-month follow-up
Automaticity
Time frame: baseline, after 4-week intervention, one-month follow-up
6-minute Walking test, 6MWT
Time frame: baseline, after 4-week intervention, one-month follow-up
Stroke impact scale, SIS
Time frame: baseline, after 4-week intervention, one-month follow-up
Mini-Balance Evaluation System Test, Mini-BESTest
Time frame: baseline, after 4-week intervention, one-month follow-up
Walking ability questionnaire
Time frame: baseline, after 4-week intervention, one-month follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Li-Ling Chuang, Ph.D. principal investigator
Chang Gung University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Treadmill Walking Training with Rhythmic Auditory Cueing (CTW+RAC) group, Cognitive Treadmill Walking Training (CTW) group and Treadmill Walking Training (TW) in people with Stroke, run by Chang Gung University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Li-Ling Chuang, Ph.D. (886-3-2118800 ext. 3177, lchunag@gap.cgu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
walking speed (m/s) under single-task walking and dual-task walking with the Stroop task (time frame: baseline, after 4-week intervention, one-month follow-up). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026.